BiVACOR, a medical device company specializing in total artificial heart (TAH) technology, has received FDA approval to expand its early feasibility study (EFS) after promising initial results. The study evaluates the BiVACOR TAH as a bridge to transplant for patients with end-stage heart failure.
The initial phase of the EFS involved five patients who received the BiVACOR TAH between July and November 2024. These patients, suffering from severe biventricular failure, were supported with the device for up to a month while awaiting a donor heart. All five patients successfully underwent heart transplants and were subsequently discharged from the hospital.
"We are thrilled to share that the first patients implanted with the BiVacor TAH achieved expected milestones utilizing the device as a bridge to heart transplant and experienced no complications," said Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR. "This has been decades in the making, and to achieve such success during first-in-human trials is extremely encouraging."
BiVACOR TAH Design and Function
The BiVACOR TAH is designed to completely replace the function of the native heart. Roughly the size of an adult's fist, the device utilizes magnetic levitation technology. It features a magnetically suspended double-sided centrifugal pump impeller as its only moving part. This design aims to minimize blood trauma and eliminate mechanical wear. The TAH is capable of providing sufficient cardiac output even for an adult male during exercise.
Unlike traditional heart pumps, the BiVACOR TAH has no valves or flexing ventricle chambers. Instead, it achieves pulsatile outflow by rapidly cycling the rotational speed of the impeller each second.
Study Expansion and Future Directions
The successful outcomes from the initial five patients have provided the FDA with sufficient data to greenlight the expansion of the EFS. BiVACOR will now enroll an additional 15 patients in the study to further evaluate the safety and performance of the TAH system. The primary endpoint of the study is to assess the device's ability to effectively bridge patients to heart transplant.
"It is incredibly rewarding to see our device provide such efficient support to the first U.S. patients," said Dr. William Cohn, BiVacor chief medical officer. "The unique design and features of the BiVacor TAH translated into an unparalleled safety profile without complications or stroke."
The global cardiovascular devices market is substantial, with a value of nearly $60 billion in the past year and projected growth to $86.6 billion by 2030, according to a GlobalData report. BiVACOR has also secured significant funding, including $13 million from the Australian Government’s Medical Research Future Fund (MRFF).
